483
Indiana University HealthFDA 483 - Indiana University Health - June 12, 2019
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An FDA inspection of Indiana University Health in Indianapolis, an establishment handling Blood Bank & HCT/P, revealed a significant issue with equipment maintenance. Specifically, cryogenic freezers used for storing human tissues were not maintained according to manufacturer's guidelines, indicating a lapse in established schedules for critical equipment. This suggests a moderate severity finding related to facility and equipment controls for HCT/Ps.
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ID · 71a93bc2-b518-45ce-b141-16f386d81fc8